Viagra Compulsory Licensing – What Becomes an (Urban) Legend Most

March 19, 2014Comments Off on Viagra Compulsory Licensing – What Becomes an (Urban) Legend Most Posted in: General Biotechnology

This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Have you heard the urban legend about Egypt’s compulsory license for Viagra, following declaration of a national emergency for erectile dysfunction? Its a whale of a tale, combining crony capitalism, low-quality generics, and a fun therapeutic category.

Just one problem – it never actually happened.

The facts are these:

In early October 2002, the New York Times published an article highlighting the recent passage of Egypt’s new intellectual property law, including updated patent law provisions intended to bring Egypt into compliance with its World Trade Organization (WTO) patent obligations by 2005.

The same article went on to say that an identified MOH official had issued a statement to the effect that it would soon authorize copy-cat products for Pfizer’s recently approved Viagra, noting that the patent law was not yet in place.

What does this mean?

There was no pharmaceutical compulsory licensing in Egypt – then or now.

In fact, by mid-2002 Egypt had implemented data exclusivity to protect the commercially valuable clinical dossiers lodged by companies with any application for marketing approval. The IP Amendments included a number of lacunae and compulsory licensing provisions that gave industry heartburn, to be sure, but were passed more than 3 years ahead of the deadline.

While Egypt’s early implementation of its data protection obligations suffered from occasional (and not uncommon) backsliding, in this case it turned out the MOH official had spoken out of turn, and was not expressing official Egyptian policy. Following consultations between the Egyptian Ministry of Commerce, the Pharmaceutical Research & Manufacturers of America (PhRMA), and the two governments, the Government of Egypt renewed its commitment to provide the required protection for pharmaceutical clinical dossiers.

Recognizing the progress made in Egypt through passage of the IP Amendments in 2002, the PhRMA 2003 “Special 301” submission to the US Trade Representative recommended that Egypt be promoted from the “Special 301” Priority Watch List to the Watch List, and supported continuing U.S. technical assistance to ensure implementation of the patent amendments and full exclusivity for clinical dossiers.

About the author:President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.